EMEA-001588-PIP01-13-M02 - paediatric investigation plan

Encorafenib

Key facts

• Invented name:
  Braftovi
• Active Substance:
  Encorafenib
• Therapeutic area:
  Oncology
• Decision number:
  P/0487/2022
• PIP number:
  EMEA-001588-PIP01-13-M02
• Pharmaceutical form(s):
  • Capsule (hard)
  • Age-appropriate oral dosage form
• Condition(s) / indication(s):
  Treatment of melanoma
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Pierre Fabre Médicament

  Tel. [phone]; E-mail: [e-mail]

• Decision type:
  RPM: decision refers to a refusal on the application for modification of an agreed PIP
• Decision date:
  02/12/2022

Decision

P/0487/2022: EMA decision of 2 December 2022 on the refusal of a modification of an agreed paediatric investigation plan for encorafenib (Braftovi), (EMEA-001588-PIP01-13-M02)

AdoptedReference Number: EMA/871494/2022